Calthek Forte 1 g tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Calthek Forte 1g tablets

paracetamol

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Always follow exactly the instructions for use provided in this leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 5 days.

Leaflet contents:

1. What Calthek Forte is and what it is used for
2. What you need to know before taking Calthek Forte
3. How to take Calthek Forte
4. Possible side effects
5. How to store Calthek Forte
6. Contents of the pack and other information

1. What Calthek Forte is and what it is used for

Calthek Forte belongs to a group of medicines called analgesics and antipyretics. Calthek Forte is indicated for the treatment of symptoms of moderate pain and fever.

You should consult a doctor if your condition worsens or does not improve after 3 days of fever or 5 days of pain.

2. What you need to know before taking Calthek Forte

Do not take Calthek Forte

• If you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Do not take more medicine than the recommended dose stated in section 3. How to take Calthek Forte.
• Avoid taking this medicine together with other medicines containing paracetamol, such as cold and flu remedies, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Consult your doctor or pharmacist before taking Calthek Forte if:

• You have kidney or liver disease.
• You regularly consume alcohol (3 or more alcoholic drinks per day). In this case, you may need a lower dose of paracetamol and should limit its use to shorter periods, as your liver may be affected. Chronic alcoholics should not take more than 2 g of paracetamol in 24 hours.
• You suffer from dehydration or chronic malnutrition, for example due to alcohol abuse, anorexia, or inadequate diet.
• You have haemolytic anaemia (caused by abnormal breakdown of red blood cells).
• You have glucose-6-phosphate dehydrogenase deficiency (an enzyme deficiency).
• You are asthmatic and sensitive to acetylsalicylic acid.
• You are taking other medicines that affect the liver.
• You are taking other medicines containing paracetamol, as this may cause serious liver damage.
• You frequently take other painkillers over long periods, as prolonged use may lead to more severe and frequent headaches. In such cases, consult a doctor, but do not increase the dose of painkiller.

Abruptly stopping long-term treatment with high doses of painkillers may cause withdrawal symptoms such as headache, muscle pain, restlessness, or fatigue, which usually resolve within a few days. If you do not feel better, consult your doctor.

Taking higher than recommended doses may cause serious liver damage. Therefore, do not exceed the maximum daily dose indicated in section 3. How to take Calthek Forte. See also section “If you take more Calthek Forte than you should”.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, consult your doctor and re-evaluate your clinical condition.

Children and adolescents

For children under 15 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

During treatment with Calthek Forte, inform your doctor immediately if:

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Taking Calthek Forte with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for tuberculosis: (isoniazid, rifampicin)
• Medicines for depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels (cholestyramine)
• Medicines used to increase urine output (loop diuretics such as furosemide)
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are receiving treatment with another medicine. In the case of treatment with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.

Inform your doctor or pharmacist if you are taking:

Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

Interference with laboratory tests:

If you are scheduled to undergo any laboratory tests (including blood and urine analyses, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Calthek Forte with food, drinks and alcohol

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is negligible or none.

3. How to take Calthek Forte

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The tablets are taken orally with a glass of liquid, preferably water.

The tablets are scored, which allows them to be split in half to facilitate swallowing.

High daily doses of paracetamol should be avoided over prolonged periods, as this increases the risk of adverse effects such as liver damage.

This medicine should only be taken when pain or fever occurs. As these symptoms subside, treatment should be discontinued. If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment must be stopped and a doctor consulted.

The recommended dose is:

Adults and adolescents over 15 years of age: The usual dose is 1 tablet (1 g of paracetamol) 3 times daily. Doses should be spaced at least 4 hours apart. Do not take more than 3 tablets (3 g) in 24 hours.

Patients with liver disease: Must consult their doctor before taking this medicine. They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses. They must not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: Must consult their doctor before taking this medicine.

Maximum dose per administration: 500 milligrams.

Due to the dosage (1 gram of paracetamol), this medicine is not indicated for this patient group.

Elderly patients: Should consult their doctor.

Use in children and adolescents

Do not use in adolescents and children under 15 years of age.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

When lower doses than 1 g of paracetamol per dose are required, other paracetamol formulations adapted to the required dosage should be used.

If you take more Calthek Forte than you should

Contact your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you have taken an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment for overdose is most effective when started within 4 hours of taking the medicine.

Patients undergoing treatment with barbiturates or those suffering from chronic alcoholism may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Calthek Forte Do not take a double dose to make up for missed doses. Simply take the missed dose as soon as you remember, then take the following doses at the recommended intervals (at least 4 hours apart).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Calthek Forte may produce adverse effects, although not everyone will experience them.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Platelet disorders (coagulation disorders), disorders of blood-forming cells in the bone marrow
• Allergic reactions (hypersensitivity)
• Depression, confusion, hallucinations
• Tremor, headache
• Abnormal vision
• Edema (abnormal accumulation of fluid under the skin)
• Abdominal pain, stomach or intestinal bleeding, diarrhea, nausea, vomiting
• Abnormal liver function, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), hepatic necrosis (death of liver cells)
• Skin rash, itching, sweating, urticaria, red spots on the skin, angioedema with symptoms such as swelling of the face, lips, throat, or tongue
• Dizziness, general malaise, fever, sedation, interaction with other medicines
• Overdose and poisoning

Very rare adverse effects (may affect up to 1 in 10,000 patients):

• Blood disorders (reduction in the number of platelets, white blood cells, and neutrophils in the blood, hemolytic anemia (abnormal destruction of red blood cells))
• Low blood sugar levels
• Hepatotoxicity (liver damage)
• Cloudy urine and kidney disorders
• Severe allergic reactions requiring discontinuation of treatment

Adverse effects with unknown frequency (cannot be estimated from available data):

Epidermal necrolysis (a potentially life-threatening skin disorder), erythema multiforme (an allergic reaction or skin infection), Stevens-Johnson syndrome (a serious, potentially life-threatening skin disorder), fluid accumulation in the larynx, anaphylactic shock (severe allergic reaction), anemia (reduction in red blood cells), liver disorders and hepatitis (inflammation of the liver), kidney disorders (severe renal failure, blood in urine, inability to urinate), stomach and intestinal disorders, vertigo.

A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with serious illness who use paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CalthekForte

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Calthek Forte

• The active substance is paracetamol.
• The other components are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable-source magnesium stearate.

Appearance of the product and contents of the pack

Oblong, white tablets, scored on one side, packed in blisters.

This medicine is available in packs of 10 tablets.

Marketing Authorization Holder

Apotheke Laboratorios, S.L.
Paseo de la Castellana 40, 8th floor
28046 - Madrid
Spain

Manufacturer

Toll Manufacturing Services, S.A.
Calle Aragoneses 2, 28108 Alcobendas
Madrid
Spain

or

Ferrer Internacional, S.A.
Calle Joan Buscalla, 1-9
08173 Sant Cugat del Vallès (Barcelona)
Spain

or

Pharmaloop, S.L.
Calle Bolivia 15, Pol. Ind. Azque
28806 Alcalá de Henares (Madrid)
Spain

Date of the most recent review of this leaflet: March 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/